MAUDE Adverse Event Report: INVAMEX INVACARE IVC FULL-ELECTRIC LOW HOMECARE BED; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number	5410LOW
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no reported malfunction/deficiency with the bed, rails, or mattress.The models of the mattress and the side rails in use at the time of the incident are unknown.The facility did advise that the patient was using an alternating pressure mattress.When these types of mattresses compress, the space between the mattress and the bed rail may increase, which can increase the risk of entrapment.Additionally, some of the patient's preexisting medical conditions may increase the patient's risk of harm by using bed rails.The 5410low user manual includes fda's "a guide to bed safety bed rails in hospitals, nursing homes and home health care: the facts" which advises that patients who have problems with memory, sleeping, incontinence, pain, uncontrolled body movement, or who get out of bed and walk unsafely without assistance, must be carefully assessed for the best ways to keep them from harm.The guide provides potential benefits and potential risks of using bed rails.One of the identified risks is bodily injury when patients or part of their body are caught between rails or between the bed rails and mattress.The guide instructs that when bed rails are used, perform an on-going assessment of the patient¿s physical and mental status; closely monitor high-risk patients.Note: the subject bed was manufactured by invacare sanford; however, this manufacturing site is no longer in production.The manufacture of these beds has been transferred to invamex, so their cfn number is being utilized for the mdr filing.Should additional information become available, a supplemental record will be filed.
Event or Problem Description
A facility administrator advised that facility staff report the patient was restless through the night.The patient was in a 5410low bed with both legs through the side rails, then she pulled her legs back through the rails.When a health assistant went to bathe the patient, she noticed the patient's left leg was deformed above the knee.The patient was lying in bed calmly.A doctor was notified, and the patient was transferred to the er and hospitalized with a closed displaced comminuted fracture of shaft of left femur.The patient had surgery.

• Brand Name: INVACARE IVC FULL-ELECTRIC LOW HOMECARE BED
• Common Device Name: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: mike simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 19123807
• Report Number: 9616091-2024-00006
• Device Sequence Number: 20743502
• Product Code: LLI
• UDI-Device Identifier: 00841447102168
• UDI-Public: 00841447102168
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 5410LOW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 59 KG